propylthiouracil

Small moleculeapproved

Approved

Jul 28, 1947

Propylthiouracil is thyroid peroxidase inhibitor used to treat hyperthyroidism, which includes hyperthyroidism due to Graves' disease and toxic multinodular goiter. Propylthiouracil is used to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole. — NCATS

Clinical trial activity

6 trials · 8 clinical orgs · 19 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jul 1, 2004 (NCT01436994)

Timeline

1940s

Jul 28, 1947
Earliest FDA Approval
Jul 28, 1947
DAVA Pharmaceuticals — NDA Secondary Org
Jul 28, 1947
Endo Pharmaceuticals — Marketing Organization
Jul 28, 1947
PH HEALTH — Marketing Organization

1970s

Jul 24, 1970
Lannett Company, Inc. — Marketing Organization
Jul 24, 1970
Chartwell Pharmaceuticals — Marketing Organization
Jul 23, 1971
Hikma — Marketing Organization
Jul 23, 1971
Quagen Pharma — Marketing Organization
Jan 9, 1973
Actavis — Marketing Organization
Aug 10, 1973
Impax Laboratories — Marketing Organization
May 6, 1974
Sun Pharmaceuticals — Marketing Organization
Dec 19, 1974
Anabolic Pharma — Marketing Organization
Mar 3, 1977
Watson Pharmaceuticals — Marketing Organization

2000s

Jan 1, 2004
Earliest Phase 3 Sponsor(trial)

2020s

Jan 1, 2021
Earliest Phase 1 Sponsor(trial)
Jan 1, 2022
Earliest Phase 2 Sponsor(trial)
May 10, 2023
Macleods Pharmaceuticals, Ltd — Marketing Organization
May 10, 2023
Neogen — Marketing Organization

Indications

Approved for

Hyperthyroidism (approved 1947)

Studied for

Mechanism of action

Thyroid peroxidaseINHIBITOR
TPO inhibitor
- Thyroid peroxidase (TPO) ↗
Type I iodothyronine deiodinase (Type-I 5'-deiodinase) (DIOI) (Type 1 DI) (5DI)INHIBITOR
DIO1 inhibitor
- Type I iodothyronine deiodinase (DIO1) ↗

Approval history

approvedJul 28, 1947

Chemistry & pharmacology

Loading structure…

SMILES

CCCC1=CC(=O)NC(=S)N1

Mol. weight: 170.232 g/mol
Lipinski Ro5: Pass
Rule of 3: Yes
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Black box warning

Sources

Also known as

2,3-dihydro-6-propyl-2-thioxo-4(1h)-pyrimidinone
2,3-dihydro-6-propyl-2-thioxo-4(1h)-pyrimidinone
2-mercapto-6-propyl-4-pyrimidone
2-mercapto-6-propyl-4-pyrimidone
2-mercapto-6-propylpyrimid-4-one
2-mercapto-6-propylpyrimid-4-one
2-thio-4-oxo-6-propyl-1,3-pyrimidine
2-thio-4-oxo-6-propyl-1,3-pyrimidine
2-thio-6-propyl-1,3-pyrimidin-4-one
2-thio-6-propyl-1,3-pyrimidin-4-one
4-propyl-2-thiouracil
4-propyl-2-thiouracil
6-n-propylthiouracil
6-propyl-2-thio-2,4(1h,3h)pyrimidinedione
6-propyl-2-thio-2,4(1h,3h)pyrimidinedione
6-propyl-2-thioxo-2,3-dihydropyrimidin-4(1h)-one
6-propyl-2-thioxo-2,3-dihydropyrimidin-4(1h)-one
6-propylthiouracil
6-propylthiouracil
6-thio-4-propyluracil
6-thio-4-propyluracil
procasil
propacil
propacil
propacil
propiltiouracilo
propiltiouracilo
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracil
propylthiouracile
propylthiouracile
propylthiouracilum
propylthiouracilum
prothiurone
prothyran
prothyran
thyreostat
thyreostat
thyreostat ii
thyreostat ii

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT05762146	Phase 2	Sep 5, 2022	Maastricht University
NCT04776499	Phase 1	Mar 18, 2021	European Commission, Maastricht University, University of Heidelberg
NCT05118542	Phase 3	Jan 1, 2019	University of Indonesia
NCT01056419	Phase 4	Jan 1, 2009	University of Ankara
NCT00846755	N/A	Mar 1, 2005	Ospedale Vito Fazzi, V. Fazzi Hospital
NCT01436994	Phase 3	Jul 1, 2004	Newcastle University

Showing 6 of 6 trials

Page 1 / 1

Organizations

Research & Development (8)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Maastricht University	Academic/Hospital	2	2	2	2021
European Commission	Government	1	0	1	2021
Newcastle University	Academic/Hospital	1	1	1	2004
Ospedale Vito Fazzi	Academic/Hospital	1	1	1	2005
University of Ankara	Academic/Hospital	1	1	1	2009
University of Heidelberg	Academic/Hospital	1	0	1	2021
University of Indonesia	Academic/Hospital	1	1	1	2019
V. Fazzi Hospital	Academic/Hospital	1	0	1	2005

8 organizations

Page 1 / 1

Marketing (20)

Organization	Org type	Relationship	Date
Abbott	For profit	MKTG	—
Actavis	For profit	MKTG	Jan 9, 1973
Anabolic Pharma	Academic/Hospital	MKTG	Dec 19, 1974
Ani Pharmaceuticals	For profit	MKTG	—
Chartwell Pharmaceuticals	For profit	MKTG	Jul 24, 1970
DAVA Pharmaceuticals	For profit	NDA2	Jul 28, 1947
Eli Lilly	For profit	NDA	—
Eli Lilly	For profit	SYN	Jul 29, 1947
Endo Pharmaceuticals	For profit	MKTG	Jul 28, 1947
Halsey	For profit	MKTG	—
Hikma	For profit	MKTG	Jul 23, 1971
Impax Laboratories	For profit	MKTG	Aug 10, 1973
Lannett Company, Inc.	For profit	MKTG	Jul 24, 1970
Macleods Pharmaceuticals, Ltd	For profit	MKTG	May 10, 2023
Neogen	For profit	MKTG	May 10, 2023
PH HEALTH	For profit	MKTG	Jul 28, 1947
Quagen Pharma	For profit	MKTG	Jul 23, 1971
Sun Pharmaceuticals	For profit	MKTG	May 6, 1974
Tablicaps	For profit	MKTG	—
Watson Pharmaceuticals	For profit	MKTG	Mar 3, 1977